Human Research Protection Office (HRPO)

IRB 101 for New Coordinators Submitting Minimal Risk Studies


Speaker: Larry Ivanco, HRPO Research Review Analyst

This session will provide a new coordinator the basic skills to manage a study that will be submitted for expedited review.  Join Larry to learn about the role and responsibilities of the IRB, submission and review process, and regulatory issues commonly encountered with minimal risk studies. Those interested in a thorough discussion of exempt studies should register for the next  Exempt 101 session. 

IRB 101 for New Coordinators Submitting Greater than Minimal Risk Studies


Speaker: Melissa Miklos, HRPO Associate Director

This session will provide a new coordinator the basic skills to manage a study that will be submitted for IRB committee review.  Join Melissa to learn about the role and responsibilities of the IRB, submission and review process, and regulatory issues commonly encountered with greater than minimal risk studies. This session will focus on the full board review process and include an introduction on the use of FDA regulated drugs and devices in research.

Data Security Essentials


Speakers: Scott Weinman, Senior Security Analyst - CSSD Information Security
                 Sean Gallagher, Security Analyst - CSSD Information Security

The Computing Services and Systems Development (CSSD) staff provide support for the research community to meet federal and other regulations that require researchers to provide a plan to protect the confidentiality of research data as part of the IRB application.  This session provides the opportunity to discuss data security issues directly with the CSSD reviewers.  

Waivers: What You Need to Know


Erin Holmes Grabowski, HRPO Quality Assessment Specialist

This presentation will go over the waiver to document informed consent, full waiver (or alteration) of informed consent, and waiver of HIPAA authorization.  The session will explain each waiver and discuss the situations in which they can be applied, as well as what is needed to justify them. This session will not cover the exception to the requirement to obtain informed consent for research involving emergency procedures (EFIC).   

New University of Pittsburgh Requirements for Reportable Events


Speakers:
Richard Guido, IRB Chair
Ann Lee, Regulatory Affairs Specialist

This is a repeat of the HRPO Seminar presented on June 12, 2018.

The Human Research Protection Office is changing the reporting requirements for protocol deviations and unanticipated problems. The changes are being made to harmonize with similarly situated Institutions and in anticipation of the roll-out of the new online submission system, PittPRO. Join Dr. Guido and Ann Lee at this session to learn what the changes will be and study teams’ responsibilities for reporting.

Exempt Submissions 101


Dana DiVirgilio, Research Review Analyst

The purpose of this session is to provide an overview of the federal criteria for “exempt” submissions.  It is often difficult to determine whether your project meets one of the exempt categories.  By attending, you will learn the basics of exemptions and be able to apply this knowledge to determine the appropriate exempt application form for your project.  The following topics will be discussed:

Vincent - Great Changes on the Horizon!


George Cerminara, University of Pittsburgh Finance

Join George Cerminara in this discussion about Vincent.  As a joint venture between the University of Pittsburgh and UPMC, Vincent was developed as the next generation of our WePay software. Vincent expands the functionality of WePay and streamlines the design around you, the user, to make the experience much simpler and more efficient.  This session will talk about Vincent and include a demo of the system.

Exempt Submissions 101


Dana DiVirgilio, Research Review Analyst

The purpose of this session is to provide an overview of the federal criteria for “exempt” submissions.  It is often difficult to determine whether your project meets one of the exempt categories.  By attending, you will learn the basics of exemptions and be able to apply this knowledge to determine the appropriate exempt application form for your project.  The following topics will be discussed:

Single IRB of Record


Michelle LeMenager, Reliance Specialist, Human Research Protection Office

The National Institute of Health (NIH) issued a federal policy that requires certain types of NIH-funded studies to use a single IRB (sIRB). The goal of this policy is to streamline the IRB review process and it goes in effect on January 25, 2018. Topics to be discussed will include:

Consent Language Does Affect Your Ability to Share Data/Specimens


Jean Barone, Director, Human Research Protection Office
Melissa Miklos, Associate Director, Human Research Protection Office

Learn about the Do’s and Don’ts when creating your consent document. Words do matter and too often restrictive wording and promises to destroy the data/specimen are included in the consent. This presentation will be discuss best practices and address the following topics: